Treatment of Myocardial Infarction With Bone Marrow Derived Stem Cells

NCT ID: NCT00275977

Last Updated: 2010-07-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2007-03-31

Brief Summary

The aim of the study is to investigate whether infusion of autologous bone marrow derived stem cells can improve cardiac function in the aftermath of a myocardial infarction.

Detailed Description

Primary coronary intervention within a few hours of a myocardial infarction has greatly reduced mortality as well as the risk of developing chronic heart failure. There are though still a large number of patients that develop symptoms of heart failure in the form of fatigue and breathlessness with physical exertion in spite of medical treatment. With the advance in stem cell technology there is now hope for the possibility of regenerating/repairing dead myocardial tissue, hence improving cardiac function.

The current study is a pilot study that is going to precede a later double blinded randomized study. The aim of the study is to evaluate patient safety, optimize procedures, and to be used in power calculation in the design of the following study.

Conditions

Acute Myocardial Infarction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Interventions

Coronary catherization and stem cell infusion

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Chestpain
• Troponin T, > 0,1ng/ml
• Succesfull revascularization of culprit lesion with PCI.
• No more than stenosis of 2 major epicardiel coronary arteries.

Exclusion Criteria

• Cardiogenic shock
• Known LVEF<45%
• Cardiomyopathy
• Atrialfibrillation or fluctuation
• Takyarytmia
• Infection
• Chronic inflammatory disease

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Odense University Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Moustapha Kassem, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Department of endocrinology M, Odense University Hospital

Locations

Department of endocrinology M, Odense University Hospital

Odense, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Malthe AM Kristiansen, MD

Role: CONTACT

mkristiansen@health.sdu.dk

+45 65504081

References

Wollert KC, Meyer GP, Lotz J, Ringes-Lichtenberg S, Lippolt P, Breidenbach C, Fichtner S, Korte T, Hornig B, Messinger D, Arseniev L, Hertenstein B, Ganser A, Drexler H. Intracoronary autologous bone-marrow cell transfer after myocardial infarction: the BOOST randomised controlled clinical trial. Lancet. 2004 Jul 10-16;364(9429):141-8. doi: 10.1016/S0140-6736(04)16626-9.

Reference Type: BACKGROUND

PMID: 15246726 (View on PubMed)

Schachinger V, Assmus B, Britten MB, Honold J, Lehmann R, Teupe C, Abolmaali ND, Vogl TJ, Hofmann WK, Martin H, Dimmeler S, Zeiher AM. Transplantation of progenitor cells and regeneration enhancement in acute myocardial infarction: final one-year results of the TOPCARE-AMI Trial. J Am Coll Cardiol. 2004 Oct 19;44(8):1690-9. doi: 10.1016/j.jacc.2004.08.014.

Reference Type: BACKGROUND

PMID: 15489105 (View on PubMed)

Other Identifiers

020

Identifier Type: -

Identifier Source: org_study_id